Description

Results-driven Regulatory Affairs and Quality Assurance Director with 16+ years of progressive leadership in biological pharmaceuticals, medical devices, IVD, and combination products. Extensive experience managing global regulatory submissions across FDA, EU MDR/IVDR, MEA, APAC, LATAM, Russia, Canada, and Turkey. Certified PRRC with demonstrated ability to build QMS from scratch, lead cross-functional teams, and drive product approvals in highly regulated environments. Fluent in 6 languages.

Languages

French
Native or bilingual
English
Native or bilingual
Arabic
Native or bilingual
Turkish
Fluent
German
Fluent
Chinese
Fluent

Workplace preferences

Can work on-site

Zurich (up to 50km)

Apoqlar
Senior Regulatory Director & Quality Assurance Consultant
PHARMACEUTICALS INDUSTRY
March 2024 - Today (2 years and 3 months)
San Francisco, United States
1 – Pharmaceutical RA & Quality GMP AMM (BD)
• • Built and maintained QMS for pharmaceutical operations in compliance with GMP, GDP, and ICH guidelines; authored SOPs and WIs from scratch.
• • Managed and submitted AMM dossiers (Modules 1 , 2 & 3) for international markets including MEA, Africa, and Europe.
• • Authored CMC variations, QOS, and safety updates; performed GMP audits of manufacturing and distribution sites.
• • Led CAPA management, deviation handling, and change control processes; ensured continuous GMP compliance.
• • Managed labelling compliance, packaging updates, and variation submissions aligned with ANSM, EMA, and regional HA deadlines.
• • Drafted distributor contracts (PRA/PVA); performed post-AMM regulatory monitoring and subsidiary quality guidance.
Mission 2 – | IEC 62304 | Cybersecurity (Apoqlar)
• • Created QMS from scratch for a startup developing AI-powered SaMD (Software as a Medical Device); defined quality processes aligned with ISO 13485 and IEC 62304.
• • Led software lifecycle management per IEC 62304; implemented software development and maintenance processes including SOUP management and verification/validation.
• • Developed regulatory strategy for AI/ML-based medical devices per FDA SaMD guidance and EU MDR Annex I requirements.
• • Ensured cybersecurity compliance per FDA cybersecurity guidance and MDCG 2019-16; produced Software Bill of Materials (SBOM).
• • Built risk management documentation per ISO 14971 integrating software failure modes and AI-specific risk controls.
• • Supported CE Mark and FDA 510(k) submissions for software medical devices; coordinated with Notified Bodies and FDA reviewers.
Regulatory Compliance (MDR, IVDR, FDA, MHRA, Health Canada) SaMD Quality Management System (QMS) intelligence artificielle Hybrid Project Management (PMP & Agile)
Align Technology
Director of Quality & Regulatory Affairs
PHARMACEUTICALS INDUSTRY
June 2022 - February 2024 (1 year and 8 months)
Zug, Switzerland
• • Member of the Senior Leadership Team; drove site regulatory strategy and quality direction.
• • Led CE Mark and 510(k) submissions; built GSPR, CER, and Risk Management Plans in full compliance with EU MDR and 21 CFR 820.
• • Managed international MD registrations: EU MDR, Art. 117, 21 CFR 820/4, ISO 13485, Middle East, Japan, Russia, Africa, APAC.
• • Supervised a team of 7 (2 Quality Managers, 1 Quality Engineer, 4 RA Specialists).
• • Oversaw complaint management, internal auditing, supplier control, document control, calibration, and CAPA programs.
• • Drove risk-based product validation and design input/output project management.
Regulatory Compliance (MDR, IVDR, FDA, MHRA, Health Canada) Risk Management Quality Management System (QMS) Atlassian JIRA Lead Auditor
DBV Technologies
Quality Director & Regulatory Affairs – Drug/Device Combination Products
PHARMACEUTICALS INDUSTRY
January 2021 - May 2022 (1 year and 4 months)
Zürich, Switzerland
• • Led regulatory strategy and submissions for new applications in USA, UK, EU, Asia, and MEA.
• • Authored and submitted BLA and EU MAA dossiers (Modules 1 & 3); managed 510(k) and CE Mark submissions for combination products.
• • Built QMS from ground up: SOPs, WIs, and regulatory documentation per EU MDR, 21 CFR 820, ISO 13485, and GMP.
• • Authored clinical trial authorizations, amendments, PIPs, Fast Track and Breakthrough designation applications.
• • Managed CMC dossier publication and variation/safety update approvals.
• • Led a team of 5; maintained active relationships with FDA, MEA, and European Competent Authorities.
Quality Management System (QMS) Regulatory Compliance (MDR, IVDR, FDA, MHRA, Health Canada) intelligence artificielle Lead Auditor Pharmaceuticals